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IRCT20080826001096N7 IRCT 2019-08-18 Research vice-chancellorship, Guilan University of Medical Sciences Investigating the effect of vaginal washing before Misoprostol insertion on ripening cervix before labor induction Investigating the effect of vaginal washing before Misoprostol insertion on ripening cervix before labor induction 2019-07-23 anticipated 164 Complete https://irct.ir/trial/40234 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible individuals are assigned blocked randomization size of 4 in sealed envelopes.The patients will be divided into two groups: vaginal washing (A) and control group (without vaginal washing) (B). Random sequences will be generated by computer software. After generating the list, each individual will be assigned a dedicated code and will be identified with this code during the study. The registration and randomization sequence are done by a resident of obstetric and gynecology. None of the participating in the study will be aware of the randomization list . Registration and randomization sequence are done by a third party, Blinding description: None of the participating in the study will be aware of the randomization list and also sealed envelopes that are numbered sequentially will be used for allocation concealment the randomization process. and envelope relating to each individual only after confirming the eligibility criteria for entry into study for him and the signature of the consent will be opened form by individual. 3 Labor induction. Intervention 1: Intervention group: : Vaginal washing with normal saline 0.9%(20 cc) is performed once before Misoprostol insertion (25 micrograms vaginal in the fornix posterior vaginal ) with a syringe. Intervention 2: Control group: Without vaginal washing, only Misoprostol suppository will be inserted (25 micrograms vaginal into the fornix posterior vaginal ) . Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Zakieh Bakhshipour
Al-zahra Hospital, Namjoo Ave., Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 54839- 41446 +98 131332496 Zakie.march88@gmail.com Rasht University of Medical Sciences scientific Seyedeh Hajar Sharami
Al-zahra Hospital, Namjoo Ave., Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 54839 -41446 +98 13 3336 9224 sharami@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) pregnant women ages 18 to 40 Having 38 to 40 week pregnancy Having singleton pregnancy Having normal fetal heart rate (FHR) Having cephalic presentation Not having a ban on normal vaginal delivery (cephalopelvic disproportion) Having no uterine contractions spontaneously and effectively (less than three contractions in 30 minutes) Having a Bishop score of less than 6 Estimation of fetal weight less than 4000 grams Candidates for termination of pregnancy (post-term pregnancy (42 weeks and more), oligohydramnios, decreased fetal movements, abdominal biophysical profile score, maternal diabetes mellitus, intrauterine growth retardation, and preeclampsia) 18 years 40 years Female Having sensitivity to known prostaglandin (with questions like skin manifestations, hives and rash, dyspnea and coughing, chest pain and blurred vision after taking prostaglandin) Having vaginal bleeding Preterm rupture of membranes Having a history of previous cesarean section or scar on the uterus Having fetal anomaly Having doubts about Chorioamnionitis O61.8 Other failed induction of labour Treatment - Drugs Treatment - Drugs Intervention group: : Vaginal washing with normal saline 0.9%(20 cc) is performed once before Misoprostol insertion (25 micrograms vaginal in the fornix posterior vaginal ) with a syringe. Control group: Without vaginal washing, only Misoprostol suppository will be inserted (25 micrograms vaginal into the fornix posterior vaginal ) . Success of labor induction. Timepoint: Post-partum. Method of measurement: Duration from induction to active phase of labor. The duration of vaginal Misoprostol to successful labor induction. Timepoint: During labor. Method of measurement: hour. Vaginal PH. Timepoint: Before and after vaginal washing. Method of measurement: Nitrazine paper. Duration from induction to end of first stage of labor. Timepoint: During labor until the end of the first stage of labor. Method of measurement: hour. Duration from induction to active phase of labor. Timepoint: During labor until the active phase of labor. Method of measurement: hour. Maternal complications (tachysystole, hyperstimulation, etc.). Timepoint: During labor. Method of measurement: Patient complaint. Neonatal complications include meconium excretion, Apgar score less than 7, admission to the NICU. Timepoint: During labor until after delivery. Method of measurement: Observations by doctor. Research vice-chancellorship, Guilan University of Medical Sciences Approved 2019-06-15 Ethics committee of Guilan University of Medical Sciences Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave., Rasht, Guilan, Iran Rasht Guilan Iran (Islamic Republic of)